Hypertension
Conditions
Keywords
Heart Age, Health education
Brief summary
This study evaluates the effectiveness of a brief Heart Age-based risk education intervention embedded in routine primary care for older adults with hypertension in China. The intervention uses routine health check data to generate a personalized one-page Heart Age report, delivered by physicians during regular follow-up visits. The trial tests whether this approach improves risk awareness and self-management behavior without disrupting clinical workflow.
Detailed description
This is a randomized controlled trial conducted at a community health center in Kunshan, Jiangsu, China. A total of 358 adults aged 60 years or older with hypertension were randomized 1:1 to receive either usual care or a personalized Heart Age report with a brief scripted physician explanation delivered during the routine consultation in which participants received and discussed their annual health-check results. The primary outcome is cardiovascular risk awareness at 3 months. Secondary outcomes include self-reported physical activity and dietary behaviors. Implementation outcomes, including feasibility, acceptability, fidelity, and consultation burden, are assessed primarily in the intervention group. Clinical indicators, including blood pressure, glucose, lipids, and body mass index, are obtained from routine health records at approximately 12 months as exploratory outcomes. An exploratory four-item medication-taking questionnaire based on the Morisky-Green-Levine measure (Morisky et al., 1986) was administered at baseline. Responses were coded Yes = 1 and No = 0, with higher scores indicating more non-adherent responses. The measure was previously misidentified in the registry as the MMAS-4. The planned follow-up assessment of medication adherence was subsequently discontinued, and medication adherence was not included in the effectiveness analysis.
Interventions
BEHAVIORALCognitive Intervention
Participants in the intervention arm will receive a personalized one-page Heart Age report based on data from their government-funded annual health check. The report is delivered by trained physicians using a standardized communication script during a routine follow-up visit. The control group receives usual chronic disease care without structured risk communication.
Sponsors
Duke Kunshan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults aged ≥60 years * Diagnosed with hypertension * Completed their government-funded annual health check within the past 3 months * Scheduled for a routine follow-up consultation within the enrollment window -Able to provide informed consent-
Exclusion criteria
* Diagnosed dementia or severe cognitive impairment * Terminal illness * Participation in another clinical intervention trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cardiovascular disease (CVD) risk awareness | 3 months | CVD risk awareness is assessed using the eight knowledge/risk-factor items from the validated Chinese version of the Attitudes and Beliefs about Cardiovascular Disease Risk Questionnaire (ABCD-C). Each item uses a True/False/Don't Know response format and is scored 1 for a correct response and 0 for an incorrect or "Don't Know" response. Item scores are summed to produce a total score ranging from 0 to 8, with higher scores indicating greater CVD risk awareness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical activity level | 3 months | Change in self-reported physical activity level, measured using an 11-level categorical scale developed for this study and adapted from the WHO Stepwise approach. Responses range from 1 (completely inactive) to 11 (vigorous activity \>25 miles/week or \>8 hours/week). Higher scores indicate greater physical activity level. |
| Change in dietary behavior: fruit intake | 3 months | Change in self-reported fruit consumption frequency, measured by the question: "On how many days per week do you usually eat fruit?" (0-7 days). Higher values indicate higher frequency of fruit intake. |
| Change in dietary behavior: table salt use | 3 months | Change in self-reported table salt use, measured by a single item adapted from the WHO STEPS questionnaire: "Do you usually add salt or salty condiments (e.g., soy sauce) at the table?" Responses on a 5-point scale: 1 = Always, 5 = Never. Higher scores indicate lower frequency of adding table salt. |
| Implementation outcomes 1: Feasibility (intervention group only) | 3 months | Measured using the Feasibility of Intervention Measure (FIM), 4 items, each scored on a 5-point Likert scale (1 = Strongly disagree, 5 = Strongly agree). Higher scores indicate greater perceived feasibility. |
| Implementation outcomes 2: Acceptability (intervention group only) | 3 months | Measured using the Acceptability of Intervention Measure (AIM), 4 items, each scored on a 5-point Likert scale (1 = Strongly disagree, 5 = Strongly agree). Higher scores indicate greater acceptability. |
| Implementation outcomes 3: Fidelity (intervention group only) | 3 months | Assessed using patient-reported and provider-reported delivery checks with categorical response options (e.g., explained fully, partially, not explained). |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORGuanzhou Wang
Duke University
Outcome results
None listed